- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07275034
Ett virtuell-verklighetsbaserat hortikulturellt odlingsprogram för äldre med subtröskelvärd depression
Ett virtuellt verklighetsbaserat hortikulturellt planteringsprogram för äldre med subtröskel depression: En randomiserad kontrollerad pilotstudie
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Subthreshold depression (SD) representerar ett tillstånd av psykologisk subhälsa mellan normala individer och klinisk depression. Det utgör ett högt riskstadium för utveckling av större depressiv störning och ett kritiskt fönster för att lindra depressiva symtom. En ledare publicerad i JAMA betonade att forskning om subthreshold depression har betydande implikationer för att utforska förebyggande och behandling av depression. Därför är det viktigt att prioritera subthreshold depression hos äldre vuxna och implementera tidiga interventioner. Flera studier indikerar att socialt engagemang, som en av de modifierbara faktorerna för depression hos äldre vuxna, aktivt kan fördröja debuten och progressionen av geriatrisk depression. Socialt engagemang omfattar flerdimensionella aktiviteter genom vilka äldre vuxna utbyter materiella och emotionella resurser och får social erkännande. Dessa inkluderar deltagande i aktiviteter, uppfyllande av sociala roller, interpersonella interaktioner, utnyttjande av sociala resurser och återställande av personligt värde. Faktorer som pensionering, sjukdom eller fysisk nedgång leder ofta till en minskning av äldre vuxnas befintliga sociala nätverk och försvagade sociala förbindelser. Detta resulterar i minskat omfång och frekvens av socialt engagemang, vilket potentiellt kan utlösa eller förvärra depressiva störningar. Omvänt, depressiva störningar själva, genom kärnsymtom som nedstämdhet och minskat intresse, ytterligare underminerar äldre vuxnas vilja och förmåga att upprätthålla relationer och delta aktivt i aktiviteter, vilket skapar en ond cirkel. En 2024-studie publicerad i The Lancet indikerar att äldre vuxna med höga nivåer av socialt engagemang uppvisar signifikant lägre depressionsrisk jämfört med de med lågt engagemang. På samma sätt föreslår en 2023-studie i Nature Aging att socialt deltagande kan minska depression genom att lindra stress, inflammation och cerebrovaskulär skada, och därmed bevara hjärnhälsa, bygga kognitiv reserv och mildra depressiva störningar.
Virtual Reality (VR)-teknik, som en ny interventionsmetod, besitter tre nyckelegenskaper: immersion, interaktivitet och simulering. Genom att replikera verklighetsbaserade miljöer såsom hem- och samhällsmiljöer, berikar den träningsupplevelsen för äldre individer med depression, hjälper dem att anpassa sig till olika sociala sammanhang och förbättrar interventionsresultat. Hortikulturell terapi, ett tvärvetenskapligt tillvägagångssätt som integrerar hortikultur, medicin och psykologi, erbjuder relativt låga behandlingskostnader med minimala biverkningar. Den spelar en positiv roll i att främja fysisk återhämtning, förbättra känslomässigt välbefinnande och förbättra sociala färdigheter. Allt fler forskningsteam utforskar VR-genererade virtuella hortikulturella miljöer och hortikulturella aktivitetsinterventioner. VR-teknik adresserar flera begränsningar av traditionell hortikulturell terapi. VR-baserade trädgårdsaktiviteter övervinner tids- och rumsbegränsningar, minskar kostnaderna och riskerna förknippade med fysisk trädgårdsarbete, och erbjuder rikare, mer personliga socialiserade hortikulturella miljöer och aktiviteter som tillgodoser olika patientbehov. Därför erbjuder integrering av VR-teknik med hortikulturell terapi patienter en mer omfattande, personlig och effektiv mentalhälsobehandlingsplan, som ger dem möjlighet att leva hälsosammare, mer positiva liv.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Fuzhou
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Fujian, Fuzhou, Kina, 350001
- Nursing school of Fujian Medical university
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inklusionskriterier:
- Ålder ≥ 60 år
- Uppfyller subtröskeldepressionsdiagnostiska kriterier: CES-D-poäng ≥ 16 på Center for Epidemiological Survey, Depression Scale (CES-D) som används i epidemiologiska undersökningar (detta kriterium är allmänt antaget i jämförbara studier)
- Inga kommunikationshinder i syn, hörsel eller tal
- Informerat samtycke
Exklusionskriterier:
- Insulinberoende diabetes
- Sköldkörtelsjukdom
- Nyligen exponerad för ett större traumatiskt stresshändelse, utan risk för självmord
- Delta för närvarande i andra liknande studier
- Kliniskt diagnosticerad med psykiska störningar som depression eller schizofreni
- Tar för närvarande antidepressiv medicin
- Allvarlig kognitiv nedsättning
- Allvarlig fysisk sjukdom eller organisk störning med nedsatt förmåga till egenvård
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Virtual Reality Intervention
Denna grupp använde ett interventionssystem baserat på virtuell verklighet för trädgårdsodling, utformat och utvecklat av forskningsteamet.
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The system comprised six progressive horticultural tasks, each associated with a distinct plant: (1) Tomato Planting, (2) Corn Cultivation, (3) Strawberry Care, (4) Eggplant Harvest, (5) Rose Growing, and (6) Sunflower Expansion.
All tasks followed the same eight standardized steps-land preparation, seed sowing, seedling fertilization, initial watering, secondary fertilization, secondary watering, pest removal, and harvesting-but were arranged in a clear gradient of increasing difficulty.
This progression was reflected in expanding planting scales, escalating task complexity, heightened cognitive load, more refined judgment requirements, and varying demands on operational precision.
Each task was performed individually by the participant using the VR headset, without any multiplayer or collaborative components, as the system was designed for personalized, self-paced intervention.
This arm of seniors maintains their daily routines and participates regularly in the nursing home's daily activities.
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Experimentell: Routine Care
The control group received routine health management over the 6-week period, which encompassed assistance with daily living activities, basic medical care (including regular health check-ups and medication management), recreational activities, and environmental cleaning, with no additional structured intervention.
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This arm of seniors maintains their daily routines and participates regularly in the nursing home's daily activities.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Subthreshold Depression
Tidsram: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks .
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The Center for Epidemiological Surveys Depression Scale (CES-D) was developed by Rirodiff at the National Institute of Mental Health in the United States. It is designed for screening depressive symptoms in older adults, comprising 20 items. Each question assesses one symptom, covering 20 distinct symptoms in total. The total score ranges from 0 to 60 points. A score ≤15 indicates no depressive symptoms, 16-19 suggests possible depressive symptoms, and ≥20 confirms depressive symptoms. The Cronbach's alpha coefficient for the Chinese population is 0.90. It is one of the most commonly used subthreshold depression epidemiological survey tools, with existing studies defining CES-D ≥16 as subthreshold depression. Translated with DeepL.com (free version) |
The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks .
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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General cognitive function
Tidsram: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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The Montreal Coanitive Asessment Scale,developed by Nasreddine in 2004 to assess participants'general cognitive function, covers eight areasof cognitive assessment, including visuospatial and executive function, naming, memory, attention, speech, abstraction, delayed recall, andorientation.
The Changsha version of the Montreal Cognitive Assessment Scale was used in this study, and its Cronbach's a coeficient was 0.846,retest reliability was 0.974, and investigator reliability was 0.969.
The score of the Montreal Cognitive Assessment Scale ranges from 0 to 30points.
The higher the score,the better the cognitive function ofthe study subjects.
The iliterate group s13, the primary school group s19 and thejunior high school and above group s24 can be judged as impaired cognitive function to correct the bias caused by education level.
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The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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Anxiety Condition
Tidsram: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately
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The self-rating anxiety scale (SAS) was designed and developed by Zung in the United States in 1971 to assess the severity of anxiety symptoms in individuals.
It demonstrates good reliability and validity, with a split-half reliability coefficient of 0.696, test-retest reliability of 0.777, and internal consistency of 0.82.
Additionally, it exhibits good construct validity .
The scale comprises 20 items, with items 5, 9, 13, 17, and 19 scored in reverse.
The scale employs a 1-4 rating scale (1 = never or rarely; 2 = a small portion of the time; 3 = a considerable portion of the time; 4 = most or all of the time).
Individuals complete the scale based on their experiences during the past week.
The total score is multiplied by 1.25, rounded to the nearest whole number to obtain a standardized score, which serves as the statistical indicator.
A higher standardized score indicates more severe anxiety levels
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The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately
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Self-Efficacy
Tidsram: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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The General Self-Efficacy Scale (GSES), developed by Schwarzer et al , was used.
It consists of 10 items rated on a 4-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree).
Higher total scores indicate higher levels of self-efficacy.
In this study, the Cronbach α coefficient was 0.81.
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The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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Sleep Quality
Tidsram: The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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This study employed the Pittsburgh Sleep Quality Index (PSQI) developed by Buysse et al. in 1989 to assess patients' sleep quality over the preceding month.
The 19-item questionnaire comprises seven components: subjective sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, hypnotic medication use, and daytime functioning.
The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
The Cronbach's alpha coefficient for this scale is 0.85.
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The intervention was conducted in November 2025, and the evaluation time was 0,6 weeks separately.
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System Usability
Tidsram: The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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System Usability Scale (SUS) Developed by Brooke et al., the scale used in this study is the Chinese version of the System Usability Scale translated and revised by Chinese scholars including Li Yongfeng.
This scale is unidimensional and consists of 10 items.
It employs a 5-point Likert scale, with scores ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree").
Positive items (Items 1, 3, 5, 7, 9) are scored positively: Actual item score = Item rating - 1. Negative items (Items 2, 4, 6, 8, 10) are scored negatively: Actual item score = 5 - Item rating.
If an item is left blank, it is assigned a score of 3. The total scale score = sum of all item scores × 2.5.
The scale has a maximum score of 100 points, with scores >60 considered usable, 70 considered good, ≥80 considered excellent, and ≥90 considered outstanding.
The Cronbach's alpha coefficient for this scale is 0.91.
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The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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Simulator Sickness
Tidsram: The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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The Simulator Sickness Questionnaire(SSQ) developed by Kennedy et al. in 1993, is a widely used tool for assessing the subjective severity of simulator sickness symptoms.
The SSQ consists of pre- and post-experiment sections.
The pre-experiment section employs the Pensacola Motion Sickness Questionnaire (MSQ) to gather information about participants' current physical condition and prior simulator experience.
The post-experiment section measures symptom severity on a four-point scale (0-3) for each symptom.
SSQ items can be grouped into three factors: nausea (e.g., sweating, difficulty concentrating, gastric awareness), eye movement disturbances (e.g., headache, eye fatigue, blurred vision), and disorientation (e.g., head fullness, dizziness with eyes open/closed, vertigo).
The SSQ can be scored in two ways: (1) Calculate the score for each factor by summing the scores of all relevant items (each factor includes 7 items), with a score range of 0-179.5
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The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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Immersion Presence
Tidsram: The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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The Immersion Presence Questionnaire (IPQ) was employed to evaluate users' sense of immersion in the experience. Developed by Schubert et al., this questionnaire was subsequently translated into Chinese and validated for reliability and validity by Liang Jiahui et al. The results demonstrated its strong reliability and validity, with a Cronbach's α coefficient of 0.82. The Chinese version comprises 13 items organized into three dimensions: spatial presence (Items 2, 3, 9), involvement (Items 1, 6, 10), and realism (Items 4, 5, 8, 11, 12, 13). Item 7 reflects overall presence. Each item employs a 7-point Likert scale ranging from -3 to 3 points, with items 10 and 12 reverse-scored. The total score ranges from -39 to 39 points, where a higher score indicates a better sense of presence experience in the virtual reality environment. Item 7 reflects overall presence. Each item uses a 7-point Likert scale ranging from -3 to 3 points, with items 10 and 12 reverse-scored. The total score rang |
The intervention will be implemented in November 2025, with the evaluation conducted after the 6-week intervention period concludes.
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Först inskickad som uppfyllde QC-kriterierna
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Andra studie-ID-nummer
- K2025-06-025
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